Harrison Et Al. - 2012 - Hospital Volume and Patient Outcomes After Cholecy
Transcript of Harrison Et Al. - 2012 - Hospital Volume and Patient Outcomes After Cholecy
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Hospital volume and patient outcomes aftercholecystectomy in Scotland: retrospective, nationalpopulation based study
OPEN ACCESS
Ewen M Harrison lecturer in surgery1, Stephen ONeill research fellow
1, Thomas S Meurs medical
student2, Pang L Wong medical student
1, Mark Duxbury clinician scientist and honorary consultant
surgeon1, Simon Paterson-Brown consultant surgeon and honorary senior lecturer
1, Stephen J
Wigmore professor of transplantation surgery1, O James Garden regius professor of clinical surgery
1
1Department of Clinical Surgery, University of Edinburgh, Royal Infirmary of Edinburgh, Edinburgh EH16 4SA, UK; 2Department of Surgery, LeidenUniversity Medical Centre, Leiden, Netherlands
Abstract
Objectives To define associations between hospital volume and
outcomes following cholecystectomy, after adjustmentfor case mix using
a national database.
Design Retrospective, national population based study using multilevel
modelling and simulation.
Setting Locally validated administrative dataset covering all NHS
hospitals in Scotland.
Participants Allpatients undergoing cholecystectomy between 1 January
1998 and 31 December 2007.
Main outcome measures Mortality, 30 day reoperation rate, 30 day
readmission rate, and length of stay.
Results We identified 59 918 patients who had a cholecystectomy in
one of 37 hospitals: five hospitals had high volumes (>244
cholecystectomies/year), 10 had medium volumes (173-244), and 22
had low volumes (
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in processes, such as the failure to rescue patients from
complications.6
Within this debate, less attention has been given to high volume,
general surgical procedures with a low risk, possibly because
robust outcomes in administrative databases are harder to
identify. In addition, since measureable outcomes (such asmortality) are better after surgery of this type, effect sizes tend
to be small and could be regarded as less clinically relevant.
Yet, in view of the large number of cholecystectomies performed
in developed countries each year, even relatively rare adverse
events contribute considerably to morbidity. Indeed, a study
examining the contribution of different surgical procedures to
total inpatient morbidity ranked inpatient cholecystectomy third
(6%) after colectomy and small bowel resection.7
Despite this, the relation between hospital volume and
cholecystectomy remains unclear. In a historical study of open
cholecystectomy, no link was shown between hospital volume
and mortality.8 Similarly, in a large contemporary series of
patients undergoing laparoscopic cholecystectomy in the UnitedStates, researchers found no association between hospital volume
and the risk of major complication or death, although open
conversion was associated with low volume centres.9 In the
acute setting where complications are more common and
outcome differences can be more prominent, higher volume
surgeons were associated with shorter lengths of stay and fewer
open conversions,10 but again no association with hospital
volume was shown.
Using a high quality national dataset which encompasses all
emergency and elective surgical procedures, we aimed to
evaluate four independent measures of patient outcome after
cholecystectomy and determine their association with hospital
volume. We characterised this link further with risk modelling
to determine the effect of age, comorbidity, and socioeconomic
status.
Methods
Study design, setting, and participants
We did a retrospective, population based study using data from
the Information Services Division of NHS Scotland. We
identified all NHS patients undergoing cholecystectomy between
1 January 1998 and 31 December 2007 in Scotland. Episode
records including all previous and subsequent encounters were
retrieved up to 31 December 2008 (web appendix, page 1).
We excluded patients from further analysis if the diagnosis
relating to the index procedure was related to carcinoma or
trauma (web appendix, page 2), or if the index procedure was
carried out in a paediatric or private hospital (web appendix,
page 3). We accounted for hospitals amalgamating or changing
name during the study period.
The study was performed in accordance with the Strengthening
the reporting of observational studies in epidemiology
(STROBE) guidelines.11 The National Services Scotland Privacy
Advisory Committee approved the study. All patient data were
anonymised. The primary investigator is a registered data
controller with the United Kingdom Information
Commissioners Office and all data were treated in accordance
with the principles of the Data Protection Act 1998.
Data validation and bias
The Information Services Division database was internally
consistent and we did no data imputation (missing data related
only to deprivation scoring). We matched a three year sample
with a centrally administered, operating theatre database, and
the concordance of matched cases was 89%. The coding of
laparoscopic to open conversions was inconsistent in earlier
years, and consequently we classified all these procedures as
open. The identities of the operating and responsible surgeons
were poorly correlated (50% concordance) and were not suitable
for surgeon volume analysis. In a second analysis, we matchedcases to a locally held audit database and saw a good correlation
for reoperation rate (98%), readmission rate (97%), and length
of stay (94%).
Factors and covariates
We defined hospital volume as the mean number of
cholecystectomies performed per hospital per year in 1998-2007.
In a manner similar to Birkmeyer and colleagues, we evaluated
hospital volume as a continuous (log transformed) variable in
the assessment of statistical significance. We then created
categorical variables by ranking institutions in order of
increasing volume and selecting cut-off points that most closely
sorted patients into three evenly sized groups with low, medium,andhigh volume (web appendix 3).3 No hospitals were excluded.
We did sensitivity analyses using different cut-off points and
an alternative 10 year cohort (1997-2006), from which we saw
no changes in the significance of model parameter estimates for
differences between hospital volume groups.
We explored models of morbidity scoring using disease codes
from ICD-9 and ICD-10 (international classification of diseases,
9th and 10th revisions) from all previous healthcare encounters,
including the Deyo modification of the Charlson score and the
Elixhauser score.12 No single method resulted in better model
performance, and Charlson score was used in the final analysis
(web appendix, page 3).3 The Scottish Index of Multiple
Deprivation (SIMD) 2009 uses an improved methodology to
provide a relative measure of deprivation in Scotland. Patients
postcodes at index procedure determined SIMD quintiles, which
were considered as a continuous variable. An SIMD score could
not be assigned for 271 patients, because they were not included
in models using SIMD. We found no significant patterns
between these 271 patients and the remainder of the cohort for
other variables or outcome measures.
Outcome measures
We determined patient death by using probability matching,
record linkage procedures between patient episodes from the
Information Services Division and by using death records from
the Registrar General of Scotland. Mortality was defined as
death occurring within 30 days of the index procedure or before
discharge (censored at 120 days). We defined 30 day reoperation
as the occurrence of any procedure in the 30 days after index
cholecystectomy involving the upper digestive tract (Office of
Population Censuses and Surveys version 4, code G) or other
abdominal organs (principally digestive; code J). We defined
30 day readmission as an emergency readmission to any Scottish
hospital within 30 days of the date of the index procedure.
Length of stay was defined as the period from the date of index
procedure to the discharge date of continuous inpatient stay
(that is, a patient who was directly transferred to another hospital
was not classified as being discharged).
Statistical proceduresWe examined initial univariable associations using 2 tests and
one way analysis of variance for categorical and continuous
predictors, respectively. All P values were two tailed. We
initially specified binary logistic regression models
conditionally, using backwards likelihood ratio methods.
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However, in all included models, factors and covariates found
to be significant in univariable models were also significant in
multivariable models. We determined goodness of fit and
included the Hosmer-Lemeshow testand predictive performance
quantified by the area under the receiver operator characteristic
curve (c statistic). The ratio of predictors to events was neverlower than 15:1.
We used bootstrap methods to derive confidence intervals in
multivariable models unless otherwise indicated. We specified
hierarchical logistic regression models to account for the
clustering of patients within hospitals. In all cases, random
coefficient models were not significantly better than random
intercept models (as determined by likelihood ratio tests). For
mortality outcomes, the multilevel model was no improvement
on the fixed effects model; however, since death after
cholecystectomy was regarded as a rare event, we used a model
including a bias correction.13 Length of stay in cholecystectomy
was particularly right skewed, making analysis difficult. The
problems of ordinary least squares and regression methods, even
using a log transformed dependent variable, are well described.14
We used a Cox proportional hazards procedure to model the
risk of discharge. The underlying hazard function was assessed
and seen to be constant, and no time dependent variables were
specified. Page 8 of the web appendix shows a generalised linear
model for comparison.
Finally, to provide a real world interpretation of the data, we
simulated predicted probabilities and absolute risk differences
fordifferent risk strata using the fixed effect models (asymptotic
normal approximation to the log likelihood, 1 000 000
simulations per quantity of interest; web appendix, page 4). 15
In particular, these procedures rely on the correct specification
of interactions between variables. We assessed all two way
interactions and identified no significant interactions in the final
models.
We specified the logistic regression models in Stata SE 11.0
(StataCorp) using commands logit and xtmelogit. We did rare
event logistic regression (relogit16), generalised linear modelling,
Cox proportional hazards modelling, and risk modelling in R
2.11.1 (R Foundation for Statistical Computing) using the Zelig17
and Survival packages.
Results
We identified 60 732 individuals as having undergone a
cholecystectomy between 1 January 1998 and 31 December
2007. Patients were excluded if the primary diagnosis was cancer(263) or trauma (12) or if the cholecystectomy was performed
in one of eight private hospitals (457) or one of four paediatric
hospitals (82), giving a final dataset of 59 918 patients and 37
hospitals. Patients were equally divided across three bands of
hospital volume: high volume (>244 procedures/year; five
hospitals, 18 425 patients), medium volume (173-244; 10, 20
534), and low volume (
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between low and high volume groups became more pronounced
(0.0030, 0.0007 to 0.0059, P=0.010; 338, 171 to 1491).
As baseline risk increased, absolute risk differences became
highly clinically significant (fig 2, right panel). Table 5 provides
examples of patients with different risk profiles. For instance,
in example 7, a man older than 70 years with significantcomorbidity presenting as an emergency and undergoing
cholecystectomy has a 15-20% probability of death. At this
level of risk, differences between hospital volume bands were
pronounced, as shown by the numbers needed to treat to harm
(low v high volume comparison 17, 95% confidence interval
nine to 74; medium v high volume 19, 10 to 143; table 5).
Reoperation and readmission rates at 30 days
The association between rates of reoperation and readmission
and hospital volume was non-linear. The medium volume group
had a greater number of reoperations than the low and high
volume groups (4.65% v 3.23% and 3.29%, respectively;
P
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procedures including open (n=7113) and laparoscopic (n=8602)
cholecystectomy, and found no significant association between
hospital procedure volume and 30 day mortality rate. 18 Khuri
and colleagues selected cohort differed from our cohort by
being older and predominately male, with the major difference
in ranges of annual hospital volume: open cholecystectomy1-39, laparoscopic cholecystectomy 0-44. All these centres
would have been classified as low volume in the current study,
making meaningful comparisons difficult.
Similarly, a smaller uncontrolled Norwegian study (n=5343)
found a linear association between hospital volume and a severe
complications index, but again, mean hospital volume was
significantly lower (>50, 25-50, and 15
cholecystectomies/year) were associated with significantly
decreased risk of a prolonged length of stay (odds ratio 0.91,
P=0.022) and reduced risk of open conversion (0.68,
P
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What is already known on this topic
Associations between hospital volume and outcome after specialist surgery are well defined and have guided healthcare servicereconfiguration for the benefit of patients
The effect of hospital volume on outcome after low risk, high volume procedures (such as cholecystectomy) is unclear
Smaller studies have shown a weak link between increased hospital volume and reduced mortality after cholecystectomy
What this study adds
Highvolume centres havelower mortality, shorter lengths of stay, and reduced ratesof reoperation and readmission after cholecystectomy.Although these relative risk differences are significant, they are irrelevant for most patients with a low baseline risk
For high risk patients, particularly those who are elderly or with comorbidity, hospital choice might be important even for electiveprocedures
Differences in hospital structures and processes should be examined; centralisation of care for higher risk patients could improveoutcomes after cholecystectomy
providing access to the data and invaluable advice, and Olivia Swann
for critically reviewing the manuscript.
Contributors: EMH is the guarantor and takes responsibility for the
integrity and accuracy of these data and the final decision to submit for
publication. EMH participated in the study design; data collection,processing, analysis, and interpretation; manuscript writing; and
construction of tables and figures. SON participated in the systematic
review, data interpretation, and manuscript writing. TM participated in
the study design; data processing, analysis, and interpretation; and
manuscript writing. PLW participated in data validation and manuscript
writing. MD, SP-B, SJW, andOJG participatedin thestudydesign, data
interpretation, and manuscript writing. The authors had full access to
all data in the study.
Funding: The study was funded by the University of Edinburgh, which
had no direct role in the study. The corresponding author had full
independence from the funding source.
Competing interests: All authors havecompleted the Unified Competing
Interest form at www.icmje.org/coi_disclosure.pdf(available on requestfrom the corresponding author) and declare: support from the University
of Edinburgh for the submitted work; no financial relationships with any
organisations that might have an interest in the submitted work in the
previous 3 years; MD, SP-B, SJW, and OJG work as consultant
surgeons in one of the institutions included in this study, constituting a
non-financial interest that may be relevant to the submitted work.
Ethical approval: Study approval was granted by the National Services
Scotland Privacy Advisory Committee. No ethical approval was required.
Patient consent: None required.
Data sharing: No additional data available.
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Accepted: 08 April 2012
Cite this as: BMJ2012;344:e3330
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Tables
Table 1| Patient characteristics by hospital volume. Data are no (%) unless otherwise stated
Hospital volumeHigh (n=18 425)Medium (n=20 534)Low (n=20 959)
54.0 (29-77)52.0 (28-74)54.0 (30-77)Age (years)*
3.0:13.5:13.2:1Male:female ratio
Admission type
12 381 (67.2)16 524 (80.5)17 374 (82.9)Elective
6044 (32.8)4010 (19.5)3585 (17.1)Non-elective
Diagnosis
14 694 (79.8)14 465 (70.4)15 924 (76.0)Cholelithiasis
2003 (10.9)4883 (23.8)4095 (19.5)Cholecystitis
535 (2.9)240 (1.2)174 (0.8)Acute pancreatitis
1193 (6.5)946 (4.6)766 (3.7)Other
Deprivation (SIMD score)
3379 (18.3)6637 (32.3)4006 (19.1)1 (high)
3894 (21.1)4616 (22.5)4995 (23.8)2
3468 (18.8)3447 (16.8)5336 (25.5)3
3637 (19.7)2855 (13.9)4234 (20.2)4
3965 (21.5)2921 (14.2)2257 (10.8)5 (low)
82 (0.4)58 (0.3)131 (0.6)Missing data
Morbidity
2339 (12.7)2577 (12.5)2505 (12.0)Charlson score >0
2695 (14.6)2973 (14.5)2982 (14.2)Elixhauser score >0
*Data are median (interquartile range).
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Table 2| Operative procedures associated with cholecystectomy. Data are no (%)
P*Hospital volume
High (n=18 425)Medium (n=20 534)Low (n=20 959)
Approach
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Table 3| Unadjusted outcomes after cholecystectomy. Data are no (%) unless stated otherwise
PHospital volume
High (n=18 425)Medium (n=20 534)Low (n=20 959)
0.0973 (0.40)112 (0.55)107 (0.51)Mortality*
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Table 4| Adjusted outcomes after cholecystectomy, by analysis
Length of stayReadmissionReoperationMortality
Cox
proportional
hazardsMultivariableUnivariableMultivariableUnivariableMultivariable*Univariable
P
HR(95%
CI)P
OR
(95%
CI)P
OR
(95%
CI)P
OR
(95%
CI)P
OR
(95%
CI)P
OR
(95% CI)P
OR
(95% CI)
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Table 4 (continued)
Length of stayReadmissionReoperationMortality
Cox
proportional
hazardsMultivariableUnivariableMultivariableUnivariableMultivariable*Univariable
P
HR(95%
CI)P
OR
(95%
CI)P
OR
(95%
CI)P
OR
(95%
CI)P
OR
(95%
CI)P
OR
(95% CI)P
OR
(95% CI)
Mixed effects hierarchical model (Hosmer-Lemeshow test, 2
11.276, df=8, P=0.187 on fixed components; area under the receiver operator characteristic curve,
c statistic 0.66).
Mixed effects hierarchical model (Hosmer-Lemeshow test, 2
7.24, df=8, P=0.511 on fixed components; area under the receiver operator characteristic curve, c
statistic 0.60).
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Table 5| Risk modelling for probability of death after cholecystectomy using simulations. Operation year for all examples was 2007
Example 7Example 6Example 5Example 4Example 3Example 2Example 1Risk factor
70707055-6955-6955-6955-69Age (years)
MaleFemaleFemaleFemaleFemaleFemaleFemaleSex
YesYesNoYesNoYesNoNon-electiveadmission
CholecystitisCholecystitisCholelithiasisCholecystitisCholelithiasisCholecystitisCholelithiasisDiagnosis
1111133Deprivation (SIMD
score)
4444400Morbidity (Charlson
score)
Probability of death (95% CI)
0.206 (0.132 to
0.298)
0.151 (0.094 to
0.226)
0.0153 (0.0086 to
0.0251)
0.048 (0.027 to
0.078)
0.0043 (0.0024 to
0.0072)
0.0088 (0.0056 to
0.0133)
0.00076 (0.00049 to
0.00113)
Low volume
0.199 (0.129 to
0.285)
0.146 (0.091 to
0.216)
0.0146 (0.0083 to
0.0238)
0.046 (0.026 to
0.073)
0.0041 (0.0023 to
0.0068)
0.0085 (0.0053 to
0.0128)
0.00073 (0.00047 to
0.00110)
Medium volume
0.147 (0.090 to
0.222)
0.106 (0.063 to
0.165)
0.0102 (0.0056 to
0.0170)
0.032 (0.018 to
0.054)
0.0029 (0.0015 to
0.0048)
0.0059 (0.0036 to
0.0090)
0.00051 (0.00032 to
0.00076)
High volume
Absolute risk difference (95% CI)
0.059 (0.014 to
0.110)
0.045 (0.010 to
0.087)
0.0051 (0.0011 to
0.0107)
0.016 (0.003 to
0.032)
0.0014 (0.0003 to
0.0031)
0.0030 (0.0007 to
0.0059)
0.00026 (0.00006 to
0.00051)
Low vhigh volume*
0.051 (0.007 to
0.024)
0.040 (0.005 to
0.079)
0.0044 (0.0006 to
0.0096)
0.013 (0.002 to
0.028)
0.0013 (0.0002 to
0.0027)
0.0026 (0.0003 to
0.0054)
0.00023 (0.00003 to
0.00047)
Medium vhigh
volume
Number needed to treat to harm (95% CI)
17 (9 to 74)22 (11 to 97)196 (94 to 908)64 (31 to 294)691 (325 to 3242)338 (171 to 1491)3871 (1963 to 17
118)
Low vhigh volume*
19 (10 to 143)25 (13 to 185)226 (104 to 1726)74 (35 to 557)798 (366 to 6216)387 (186 to 781)4431 (2120 to 34
681)
Medium vhigh
volume
*P=0.010.
P=0.023.
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Figures
Fig 1 Total number of cholecystectomies performed per year in 1998-2007
Fig 2 Mean number of cholecystectomies performed per year in 1998-2007, by hospital volume group
Fig 3 Mean annual hospital volume per institution. Each bar represents one of 37 hospitals in Scotland that performedcholecystectomies during the study period
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Fig 4 Risk modelling using simulation procedures. Left panel shows probability of death, reoperation, and readmission byhospital volume group for elective (example 1 in table 5) and non-elective (example 2 in table 5) cholecystectomy in patientsat standard risk (operation year 2007, age 55-69 years, female, SIMD score 3, Charlson score 0). Shaded area=95%confidence interval. Right panel shows probability of death, reoperation, and readmission in the elective setting by hospitalvolume group as a function of age, SIMD score, and Charlson score (operation year 2007, female, elective admission,cholelithiasis diagnosis).
BMJ2012;344:e3330 doi: 10.1136/bmj.e3330 (Published 23 May 2012) Page 14 of 14
RESEARCH